Amgen, GSK Pediatric Oncology Studies Could Change Based on Advisory Committee Comments
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s pediatric oncology subcommittee will consider the best study designs to isolate pediatric clinical benefit in Amgen’s blinatumomab and whether pediatric use can be extrapolated from adult data in GSK’s trametinib.
You may also be interested in...
Glaxo’s Emerging BRAF/MEK Melanoma Combo Threatens Roche’s Zelboraf
Phase I/II data for Glaxo’s BRAF/MEK combination of dabrafenib and trametinib, both pending FDA approval as single agents, suggest compelling efficacy. The combination may see off-label use if the drugs are approved as monotherapies, though payment could be a big hurdle.
Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director
Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.